Washington Update

NIH Working Group Provides Second Interim Report on Animal Research

By: Naomi Charalambakis
Thursday, December 17, 2020

On December 11, the Working Group on Enhancing Rigor, Transparency, and Translatability in Animal Research presented its second interim report to the National Institutes of Health (NIH) Advisory Committee to the Director (ACD). Established in June 2019, the ACD Working Group is charged with developing recommendations to strengthen rigor, reproducibility, and transparency of animal studies through improved experimental design, enhanced training, and streamlined results reporting.

Several themes of the interim report were commensurate with FASEB’s recommendations to the working group earlier this year as well the 2016 report, Enhancing Research Reproducibility. For example, Barbara Wold, PhD, co-chair of the working group, described the importance of extrinsic factors such as air exchange rates, room temperature, and cage density on biological responses. Therefore, the working group recommends investigators track and report these and other elements throughout the lifespan of the research project, from study design to publication. To determine which measures of impact can and should be systematically recorded, the working group advised NIH to establish a task force that provides both long-term oversight and dedicated funds for controlled randomized trials to test the effect of extrinsic variables in animal studies.

Throughout her report, Dr. Wold emphasized how numerous components contribute to the irreproducibility of animal studies. While concise checklists and reporting guidelines are effective tools to improve vague methodology reporting, the working group concluded that their effectiveness is contingent upon strong compliance. As proposed in FASEB’s comments to the working group’s Request for Information, Dr. Wold shared the group’s recommendation to extend the current page limit of the Research Strategy section of grant applications and specifically request how investigators will address scientific rigor. Suggested elements for this new section, “Elements of Rigor,” include randomization, sample-size estimation, blinding, and data analysis plan.

The working group also provided recommendations about preregistration of animal studies, a method intended to enhance scientific reproducibility by requiring researchers to describe and register their study methodologies prior to data collection. While this approach improves data quality by preventing selective reporting and other forms of biases, possible challenges such as compromised confidentiality and increased administrative burden remain unresolved. In accordance with FASEB’s recommendation, the working group proposed developing a program to raise awareness of this topic, address associated concerns, and prioritize contexts in which preregistration would be most useful, such as late-stage preclinical animal studies prior to clinical trials.

Working group members will continue deliberations and present an update during the next ACD meeting scheduled for June 2021.